immunotherapy against CanCers(position of sellular therapy)
符合美国CLIA标准的高通量测序临床试验研发案例分享
孙洪业博士现场分享了归国后在药明康德基因中心组建的努力。包括该中心如何利用高效、整合地运用基因组学最新技术，推动药物研发、临床试验以及个性化治疗事业进步。
孙博士就进行中的3个临床相关项目做了分享。
符合美国CLIA标准的高通量测序临床试验研发案例分享
视频内容主要包括：药明康德基因中心的使命，基因中心的成就和服务范畴，基因组学能力建设：顶级平台，进行中的临床相关项目等。
Study the pathologiCal features of diseases using induCed pluripotent stem Cells derived form patient's somatiC Cells
The limited experimental aCCess to disease-affeCted human tissues has severely impeded the eluCidating of moleCular meChanisms underlying disease development. Generation of induCed pluripotent stem Cells (iPSCs) by over-expression of defined transCription faCtors in somatiC Cells, in partiCular in those from patient somatiC Cells, presents an attraCtive and promising approaCh to model the early stages of diseases in vitro and to sCreen novel biomarkers as well as therapeutiC mediCines. ReCently, many researCh groups have independently reported that patient-speCifiC iPSC-derived Cells reCapitulated multiple features of pathologiCal events of a partiCular disease, offering experimental evidenCe of utilizing patient-speCifiC iPSCs to model diseases and reevaluate the Current therapies. We have derived iPSC lines using somatiC Cells of patients suffering from Klinefelter's Syndrome (KS) and Alzheimer's Disease (AD) and explored the possibility to use these iPSC lines to reCapitulate the pathologiCal features of the diseases. Our results show that patient's speCifiC iPSC lines provide good opportunity to study the development and treatment of diseases.
Regenerative mediCine for brain and nerve repair
We isolated and propagated neural stem Cells from the exposed brain tissue of the patients with open brain trauma, and then implanted neural stem Cells with MRI-guided stereotaCtiC deviCe for the patients. Within 2-years follow-ups, the patients were investigated for funCtional reCovery. Contrast to the Case Control group, implantation of neural stem Cells was assoCiated with a signifiCant improvement in patient's neurologiCal funCtion. Investigations of stem Cell therapy have required analysis of the fate and migration of implanted neural stem Cells. Here, We demonstrate the feasibility of labeling human neural stem Cells and retinal stem Cells with nanopartiCle and traCking of implanted Cells in monkey and human Central nervous system (CNS). This data demonstrates the possibility of stem Cell therapy in CNS and ColleCtively provide neCessary foundation for overComing Challenges to the enhanCement of translational regenerative mediCine of brain and optiC nerve injury.
Novel signaling by the IKK Complex
Signal transduCtion plays a pivot role in regulating Cell funCtions, from proliferation, differentiation, programmed Cell death, and transformation. Deregulation of signal transduCtion Could lead to various human diseases even CanCer. ExtraCellular signals are transmitted into Cells via an intraCellular signaling network that is Composed of multiple signaling pathways, diCtating Cellular funCtions, suCh as growth, differentiation, programmed death (apoptosis) and transformation.
Although we have learnt a great deal about the arChiteCture of the intraCellular signaling network, our understanding of its biology is limited. The work in my laboratory foCuses on eluCidating moleCular meChanisms underlying plastiCity and speCifiCity of intraCellular signaling network using C- Jun N-terminal protein kinase (JNK) and IkB kinase (IKK)/NF-kappaB as moleCular probes and understanding the impaCt of deregulating the intraCellular signaling network on human diseases
POCT类体外诊断试剂技术审评基本要求
POCT类体外诊断试剂涉及产品的类别主要包括注册申报的二、三类，在技术审评过程中根据不同产品的特性有针对性地进行，例如常规的生化免疫属于二类，传染病、毒品属于三类。二类三类产品的审评要求差别很大。进口的所有POCT产品都会在医疗器械技术审评中心进行技术审评，国产的POCT二类产品在省食药监做技术审评，三类产品的技术审评在国家食品药品监督管理局医疗器械技术审评中心。安娟娟同时提到，国家食品药品监督管理局医疗器械技术审评中心将根据产品的风险程度以及在注册过程中问题比较集中的产品编写指南，已完成自测血糖监测系统，即将完成HIV临床POCT产品指南。
HIV、HCV快速检测需求及现状
蒋岩描述了HIV、HCV快速检测需求及现状。中国食品药品检定研究院肝炎室研究员周诚作“乙肝快速检测试剂在POCT中的应用及标准探讨”的报告。
蒋岩认为：国内HIV感染病例逐年上升，急需进行POCT快速地和更早地检测，由于HIV筛查与确诊存在时间差，先用POCT进行筛查，对阳性样品进行确诊，再检测CD4以便确定HIV耐药性。
新医改大背景下，中国POCT发展路径的探讨
徐建新认为：大力推广POCT产品国产化，应进一步整合成本、质量、技术和服务以便形成综合优势。国内POCT检测主要集中在二、三医院，对高通量的POCT仪器需求大。国内各生产商应跨界创新，优势互补，形成合力，才能对抗世界500强企业的产品。发展第三、四代POCT仪器是必由之路。